CN115414571A - Guidewire device with shapeable polymer tip - Google Patents

Abstract

The present disclosure relates to a guidewire device having a shapeable tip and effective torquing capabilities. The guidewire device includes a core having a proximal section and a tapered distal section. The tube structure is coupled to the core such that the tapered distal section of the core extends into and distally beyond the tube structure. The portion of the core that extends distally beyond the tube forms a shapeable tip. A polymeric cover wraps the ends. The tip is configured to reduce the tendency of the spring force from the tube structure to break the custom shape of the tip.

Description

Guidewire device with shapeable polymer tip

The present application is a divisional application of an invention patent application (application date is 7/10/2017, application number is 201780057199.3, invented under the name "guide wire device with formable polymer tip") by vascular science co.

Cross Reference to Related Applications

The present application claims priority and benefit from U.S. patent application Ser. No. 15/611,344 entitled "GUIDEWIRE DEVICES HAVING SHAPEEABLE POLYMER TIPS (GUIDEWIRE device with SHAPEABLE POLYMER tip)" filed on 6/1 of 2017 and U.S. provisional patent application Ser. No. 62/363,760 entitled "GUIDEWIRE DEVICES HAVING SHAPEEABLE TIPS (GUIDEWIRE device with SHAPEABLE tip)" filed on 18 of 2016. All of the above applications are incorporated herein by reference in their entirety.

Background

Guidewire devices are commonly used to guide or guide catheters or other interventional devices to a target anatomical location within a patient. Typically, a guidewire enters and passes through the vasculature of a patient in order to reach a target location, which may be at or near, for example, heart or neurovascular tissue of the patient. Radiographic imaging is often used to help navigate the guidewire to the target location. In many cases, a guidewire is left in place within the body during an interventional procedure, where the guidewire may be used to guide multiple catheters or other interventional devices to a target anatomical location.

Some guidewire devices are configured with a curved or bent tip to enable an operator to better navigate a patient's vasculature. With such a guide wire, the operator can apply a torque to the proximal end of the guide wire or an attached proximal handle in order to point the tip in a desired direction. The operator can then further guide the guidewire in a desired direction within the vasculature of the patient.

Adjusting the flexibility of the guide wire device (in particular the distal section of the guide wire device) is also a problem. In many cases, a relatively high level of flexibility is desirable in order to provide the guidewire with sufficient bendability to enable the guidewire to angularly reach the target area through tortuous bends and curves of the vasculature passageway. For example, guiding a guidewire to portions of the neurovasculature requires the guidewire to pass through tortuous pathways, such as carotid siphons and other tortuous pathways.

Another problem associated with guidewire devices is the ability of a given guidewire device to transmit torque from the proximal end to the distal end (i.e., the "torqueability" of the guidewire device). As more of the guidewire enters and passes through the vasculature passageway, the amount of frictional surface contact between the guidewire and the vasculature increases, preventing the guidewire from easily moving through the vasculature passageway. A guidewire with good torqueability enables torque forces at the proximal end to be transmitted through the guidewire to the distal end, thereby enabling the guidewire to rotate and overcome frictional forces.

Some guidewire devices include a distally placed micromachined hypotube (hypotube) over the distal end of the guidewire core in order to further distally direct the applied torsional force toward the end of the device. Because the torsional forces are transmitted primarily through the outer section of the cross-section of the member, the tube is configured to provide a path for transmitting an increased amount of torque compared to the amount of torque transmitted by a guide wire core that is not sheathed.

While the described guidewire device provides many benefits, several limitations still exist. For example, many design features of a guidewire with a torque-transmitting tube, while serving to provide increased torque transmission, are detrimental to and limit the formability of the guidewire tip.

Disclosure of Invention

The present disclosure relates to a guidewire device having a shapeable tip and an effective torque. In one embodiment, a guidewire device includes a core having a proximal section and a distal section. The distal section may taper to a smaller diameter than the proximal section. The tube structure is coupled to the core such that the distal section of the core enters and distally protrudes out of the tube structure to form a shapeable tip. The guidewire device also includes a coil that is wrapped around at least a portion of the distal portion of the core. The coil is positioned such that a proximal portion of the coil is disposed between the outer surface of the core and the inner surface of the tube structure, and such that a distal portion of the coil extends distally beyond the tube structure to encase at least a portion of the shapeable tip. The guidewire device also includes a polymeric cover that wraps around at least a portion of the distal portion of the coil. The tip is configured to reduce the tendency of the spring force from the tube structure to break the custom shape of the tip.

In some embodiments, the guidewire device further comprises a braided material coupled to and extending distally from the tubular structure. In some embodiments, the woven material is embedded within the polymeric cover.

In one embodiment, the core is formed from and/or includes stainless steel, the tube structure is formed from and/or includes a superelastic material, such as nitinol, and the coil is formed from and/or includes a radiopaque material, such as platinum.

In some embodiments, the tubular structure includes a plurality of fenestrations (fencing) defining a plurality of axially-extending beams coupled with a plurality of circumferentially-extending rings. The tube structure may include one or more of a single beam cutout pattern, a double beam cutout pattern, a triple beam cutout pattern, or a cutout pattern of more than three beams. In some embodiments, a rotational offset is applied between successive segments to minimize the preferred direction of bending along the length of the tube structure.

Additional features and advantages will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the embodiments disclosed herein. The objects and advantages of the embodiments disclosed herein will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the embodiments disclosed herein or as claimed.

Drawings

In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings, in which:

FIGS. 1A and 1B illustrate an exemplary embodiment of a guidewire device that provides effective torquing capabilities and has a polymer wrapped around a shapeable tip;

FIG. 2 shows another embodiment of a guidewire device having a shapeable tip with a braided material embedded within a polymeric covering;

fig. 3-8 illustrate various exemplary cut patterns that may be formed in a tube of a guidewire device; and

fig. 9-11 illustrate various distal tip configurations that may be used with a guidewire device.

Detailed Description

Introduction to

The present disclosure relates to guidewire devices that provide effective anatomical navigation capabilities. The ability to guide and steer the guidewire to the target anatomical location depends on balancing and optimizing the tradeoff between torquing ability and ability to maintain a shaped tip. The guidewire device can include a shapeable tip to allow an operator to point the distal tip in a desired direction within the vasculature by rotating the tip. However, if the torquing capability of such a guidewire device is insufficient, the operator will not be able to transmit a torquing force all the way to the shaped distal tip to control the orientation of the shaped distal tip. This obstacle will become more problematic as the guidewire device is advanced further into the vasculature and is subject to increased frictional resistance. In addition, if the guide wire device is unable to properly form and maintain the shaped tip, its ability to adjust the tip orientation is limited, making intravascular navigation more difficult.

Embodiments described herein provide one or more features that balance and/or optimize the relationship between the ability of the guidewire to twist and the ability to form and maintain a shaped tip. The guidewire is responsive to operator manipulation during guidewire deployment and provides effective navigation performance by enabling the shaped distal tip to receive transmitted torsional forces.

In some embodiments, the shapeable tip allows an operator to customize the shapeable tip, such as by manually shaping the tip prior to deploying the guidewire device within the patient vasculature. Thus, the operator can customize the shaping of the distal tip according to conditions and/or preferences specific to a given application. The guidewire device is also configured to efficiently transmit torque while maintaining the shaped tip. At least some embodiments described herein include tips that are capable of maintaining a bent or curved shape throughout a procedure or over multiple procedures, or even indefinitely, until a counteracting reshaping force is encountered.

Guidewire device with shapeable tip

Fig. 1A and 1B illustrate an exemplary guidewire device 100 having an effective shapeable tip. Fig. 1A shows a side view of the device and fig. 1B shows a cross-sectional view of the device. The guidewire device 100 includes a core 102. Tube 104 is coupled to core 102 and extends distally from the point of attachment to core 102. As shown, the distal section of the core 102 extends into the tube 104 and is surrounded by the tube 104. In some embodiments, the core 102 includes one or more tapered sections such that the core 102 can fit within and extend into the tube 104. For example, the distal section of the core 102 may be ground so as to taper to a smaller diameter at the distal end. In this example, the core 102 and the tube 104 have substantially similar outer diameters at their attachment points 103 adjacent and attached to each other.

The tube 104 is coupled to the core 102 (e.g., using adhesives, brazing, and/or welding) in a manner that allows torsional forces to be transferred from the core 102 to the tube 104 and thereby further transferred distally through the tube 104). Medical grade adhesive/polymer may be used to couple tube 104 to core wire 102 at one or more points (e.g., including attachment points 103).

As explained in more detail below, the tube 104 is microfabricated to include a plurality of cuts. The arrangement of the cuts forms a cut pattern that advantageously provides effective formability near the distal tip of the guidewire device 100 while also maintaining good torqueability. For clarity, the cut pattern is not shown in fig. 1A to 2, but will be described with reference to fig. 3 to 8.

In some embodiments, the proximal section 110 of the guidewire device 100 extends proximally to a length necessary to provide sufficient guidewire length for delivery to the targeted anatomical region. The proximal section 110 typically has a length in the range of about 50cm to 300cm (about 19.69 inches to 118.11 inches). The proximal section 110 may have a diameter of about 0.36mm (about 0.014 inches), or a diameter in the range of about 0.20mm to 3.175mm (about 0.008 inches to 0.125 inches). The distal section 112 of the core 102 may taper to a diameter of about 0.051mm (about 0.002 inches), or a diameter in the range of about 0.025mm to 1.27mm (about 0.001 inches to 0.050 inches). In some embodiments, the length of the tube 104 is in the range of about 3cm to 100cm (about 1.18 inches to 39.37 inches). The tube 104 may be formed from and/or include a superelastic material, such as nitinol. Alternatively, the tube 104 may be formed from and/or include a linear elastic material (e.g., having a recoverable strain of at least about 6%). The portion of the device that extends distally beyond the tube 104 (referred to as the tip 106) can measure about 0.5cm to 5cm in length, or about 1cm to 3cm in length.

In some embodiments, the distal section 112 of the core 102 tapers to a circular cross-section. In other embodiments, the distal section 112 of the core 102 has a flat or rectangular cross-section. The distal section 112 may also have another cross-sectional shape, such as another polygonal shape, an oval shape, an irregular shape, or a combination of different cross-sectional shapes at different regions along its length.

Typically, the user will shape the distal end of the guidewire device 100 by manually bending, twisting, or otherwise manipulating the distal end of the guidewire device 100 (approximately) 1cm to 3cm into the desired shape. The illustrated guidewire device 100 includes a distal tip 106 that extends distally beyond the tube 104. The tip 106 is configured to be formable such that an operator may manually bend, twist, or otherwise manipulate the tip 106 into a desired shape. In some embodiments, tip 106 includes one or more shapeable members formed of stainless steel, platinum, and/or other shapeable materials. In a preferred embodiment, the tip 106 comprises one or more components formed from a material that exhibits work hardening properties such that the tip, when formed (i.e., plastically deformed), provides a higher modulus of elasticity in the formed section than prior to forming.

The coil 114 is positioned partially within the tube 104 over at least a portion of the distal section 112 of the core 102. Coil 114 extends distally beyond tube 104 to form a portion of tip 106. The coil 114 is preferably formed of one or more radiopaque materials, such as platinum group, gold, silver, palladium, iridium, osmium, tantalum, tungsten, bismuth, dysprosium, gadolinium, and the like. Additionally or alternatively, the coil 114 may be formed at least partially from stainless steel or other material that is effective to retain a shape after being bent or otherwise manipulated by a user.

In the illustrated embodiment, the coil 114 is disposed at or near the distal end of the device and extends a distance proximally toward the attachment point 103. In the illustrated device, a majority of the length of the coil 114 extends distally beyond the tube 104. In other embodiments, the coil 114 may extend further proximally. The coil 114 may extend 1cm, 2cm, 4cm, 6cm, 8cm, 10cm, 12cm, 15cm, 20cm, 25cm, 30cm, or 35cm from the distal end, or may extend a distance in a range defined by any two of the foregoing values.

In some embodiments, the section of the coil 114 that extends distally beyond the tube 104 may be formed of a different material than the more proximal section of the coil 114. For example, the distal section of coil 114 may be formed of stainless steel and/or other materials that preferably provide effective formability, while the proximal section of coil 114 is formed of platinum or other materials that preferably provide effective radiopacity. In some embodiments, the coil 114 is formed as one integral piece. In other embodiments, the coil 114 includes a plurality of individual sections that are positioned adjacent to one another in a stacked orientation and/or interlocked by an interwoven coil. Additionally or alternatively, the individual sections may be brazed, adhered, or otherwise secured to one another to form the complete coil 114.

Although the illustrated embodiment shows a space between the outer surface of the coil 114 and the inner surface of the tube 104, it should be understood that this is schematically illustrated for ease of visibility. In some embodiments, the coil 114 is sized to fill a larger proportion of the space between the core 102 and the tube 104. For example, the coil 114 may be sized to abut against both the outer surface of the core 102 and the inner surface of the tube 104. Some embodiments may include a space for at least a portion of the guidewire device 100 between the core 102 and the tube 104 where the tube 104 and the core 102 are coextensive.

The portion of the coil 114 disposed within the tube 104 may be advantageously used to tamp the space between the core 102 and the tube 104 to conform the curvature of the distal section 112 of the core 102 to the curvature of the tube 104. For example, when a curvature is formed in the tube 104, a section of the tightly packed coil 114 acts as a packing between the tube 104 and the distal section 112 to impart the same curvature to the distal section 112. Instead, the core of a guide wire device that dispenses with such a tampon may not follow the same curve as the tube, but may extend until against the inner surface of the tube, after which it is forced to bend.

As shown, the tip 106 extends more distally than the tube 104. The illustrated configuration advantageously allows the tip 106 to be shaped into a desired position (position) relative to the tube 104 and the rest of the guidewire 100 and remain in the shaped position for a sufficiently long period of time. The illustrated tip 106 is capable of maintaining a formed configuration against reaction forces exerted by the tube 104 itself, as compared to guidewire devices that rely on formability of the tube or on a formable member that is more fully disposed within the tube.

Additionally, as described more fully below, the tube 104 may include a cut pattern that maintains effective torquing capabilities while also providing sufficient flexibility at the distal region of the tube 104 to avoid disrupting the customized shape of the tip 106. In a preferred embodiment, the shapeable distal section of the core has a stiffness that can withstand the expected bending forces from the tube acting on the shaped distal section of the core. In some embodiments, the shapeable distal section of the core is formed from a material or combination of materials that provides an elastic modulus that is about 1.5 to 4 times or about 2 to 3 times greater than the elastic modulus of the material used to form the tube.

In contrast to the illustrated embodiment, a guidewire device that relies on the shaping of the tube to provide the desired distal tip shape will not be able to maintain the shaped configuration or will only be able to maintain the shaped configuration for a relatively short period of time. This degenerative effect on the shaped tip occurs at least in part because the tube structure is typically formed from nitinol or other superelastic material. These tubes will be biased toward their original (e.g., straight) attitude when bent or formed and will exert a restoring force on any formable internal components, resulting in deformation of the tip and loss of custom shape.

Typically, a guidewire that terminates distally in a tube structure or otherwise relies substantially on bending of the tube structure to shape the tip will have a shaped tip prior to deployment, for example. However, during use of the guidewire, the shaped tip will be lost or degraded as the superelastic tube flexes toward its original shape, which is opposite the desired tip shape. In contrast, the embodiments described herein provide the ability for the tip to be formable without subjecting adjacent components of the guidewire device to a deformation restoring force.

The illustrated guidewire device 100 also includes an outer polymeric covering 118 formed from a medical grade polymeric material. A polymeric cover 118 is bonded to and wraps the coil 114 and the distally extending section of the core 102. The polymeric cover 118 advantageously provides an atraumatic cover having a high relative flexibility. The high relative flexibility allows the tip 106 to be custom shaped without being subjected to reactive elastic or superelastic restoring forces. As shown, the polymeric material forming the polymeric cover 118 may also extend over the distal end of the core 102 to form an atraumatic terminal 120.

In some embodiments, the polymeric cover 118 is doped with a radiopaque substance, such as barium, bismuth, tungsten, and the like. For example, in embodiments where the coil 114 is formed of a relatively less radiopaque material (e.g., stainless steel), the polymeric covering 118 may be configured to provide sufficient radiopacity to the tip 106.

In some embodiments, the polymer used to form the polymeric cover 118 is bonded to one or more interior portions of the tube 104. For example, an amount of polymeric material may be positioned within the tube 104 to help plug the space between the core 102 and the tube 104. In some embodiments, a polymer may be used as an alternative to some or all of the padding provided by the coil 114, such that the coil may be omitted or adjusted with respect to outer diameter, coil wire size, coil spacing, and/or length.

The medical grade polymeric material may be formed from and/or include one or more medical grade adhesives. In some embodiments, for example, the polymeric material may be an acrylate-based adhesive that is curable by application of ultraviolet and/or visible light. The polymeric material may also include one or more elastomeric fillers, adhesion promoters, leveling agents, and/or cure promoters.

Fig. 2 shows an alternative embodiment of a guidewire device 200 having a polymer covered braided section 218 forming a portion of a shapeable tip 206. The guidewire device 200 can be constructed in a similar manner to the guidewire device 100 of fig. 1, and like reference numerals refer to like features/components. Accordingly, the guidewire device 200 includes a core 202 having a proximal section 210 and a distal section 212. The distal section 212 extends into and distally beyond the tube 204 to form a shapeable tip 206. The tube 204 may be adhered to the core 202 at the adhesion point 203. A coil 214 formed of a radiopaque and/or formable material wraps around at least a portion of the core 202 that extends distally beyond the tube 204 and may extend proximally to be partially within the tube 204.

In this embodiment, the distal tip 206 includes a polymer covering braid 218. The braid 218 surrounds at least the distal extension of the coil 214 and may serve as an embedded structure of polymeric material. The braid 218 is advantageously provided to transmit some torque from the tube 204 to the distal tip 206 while still providing effective flexibility, allowing the tip 206 to remain in the formed configuration. The braid 218 may be formed of and/or may include a suitable metal mesh material, such as a stainless steel mesh. The polymeric material in which the braid 218 is embedded may include a radiopaque filler, such as barium sulfate and/or any other radiopaque material described herein.

Incision pattern

Fig. 3-8 illustrate exemplary embodiments of tube cut patterns that may be used in one or more of the guidewire device embodiments described herein. For example, the tube 104 of the embodiment shown in fig. 1 and 2 may be cut according to one or more of the configurations shown in fig. 3-8.

The cut patterns are named herein according to the number of axially extending beams disposed between each pair of adjacent circumferentially extending rings. Fig. 3 and 4 show a "single beam" cut pattern, fig. 5 and 6 show a "double beam" cut pattern, and fig. 7 shows a "three beam" cut pattern. Other embodiments may include more than three beams between each pair of adjacent rings (e.g., a four-beam cutout pattern, a five-beam cutout pattern, etc.).

The tubular structure 304 shown in fig. 3 includes a single beam 332 disposed between each pair of adjacent rings 334. Pairs of adjacent beams may alternate 180 degrees as shown. Additionally or alternatively, the sections may include beams positioned on a single side along the length of the tube, as shown by beams 432 and rings 434 of tube 404 of fig. 4.

The tubular structure 504 shown in fig. 5 includes a pair of circumferentially opposed beams 532 disposed between each pair of adjacent loops 534. The respective beams 532 in each pair of beams may be symmetrically circumferentially spaced apart (i.e., about 180 degrees), as shown in fig. 5. Alternatively, the respective beams may be circumferentially asymmetric, as shown by beams 632 and rings 634 of tube 604 of fig. 6. The tubular structure 704 shown in fig. 7 includes triad of beams 732 disposed between each pair of adjacent rings 734. The respective beams in each triad may be symmetrically circumferentially spaced (i.e., about 120 degrees) as shown, or may be positioned according to some asymmetric arrangement.

Generally, the greater the number of beams left between each pair of adjacent rings, the greater the stiffness of the tube. Thus, the cut pattern may be selected to provide a desired flexibility profile along the length of the tube. The cutting spacing, width and/or depth may also be varied to provide the desired flexibility characteristics. For example, a tube configuration may include a proximal section with relatively low flexibility and relatively high torque capacity that rapidly progresses to a distal section with relatively high flexibility and relatively low torque capacity. Advantageously, the flexibility provided by such a cut pattern can prevent or minimize the tube from causing shape deformation of the inner structure of the guidewire (e.g., core), such that the customized shape of the tip can be better formed and maintained.

A section of pipe having a double beam cutout pattern of substantially circumferentially equidistantly spaced beams (as shown in fig. 5) typically has a relatively high torque transmitting capacity and relatively low flexibility, while a section of pipe having asymmetrically spaced beams (as shown in fig. 6) typically has a torque transmissibility and flexibility between the symmetric spacing Liang Tuan and the single beam pattern (as shown in fig. 3). The smaller the circumferential symmetry of a corresponding pair of beams is positioned, the closer the resulting beams will be in the circumferential direction, and thus the more similar the asymmetric double beam cutout pattern will be to the single beam cutout pattern. Thus, such an asymmetric double beam pattern may be used as a transition between a symmetric double beam pattern and a single beam pattern.

The cut pattern may form "segments" of repeating structural units along the length of the tube. In a typical single beam embodiment, a single segment may be defined as a first beam 332 disposed between two adjacent rings 334 (one proximal ring and one distal ring) and a second opposing beam 332 extending from the distal ring and rotationally offset about 180 degrees relative to the first beam 332. Similarly, in a typical dual beam embodiment, a single segment may be defined as a first pair of beams 532 disposed between two adjacent rings 534 (one proximal ring and one distal ring), and a second pair of beams 532 extending from the distal ring and rotationally offset about 90 degrees relative to the first pair of beams. Similarly, in a typical three beam embodiment, a single segment may be defined as a first triad beam 732 disposed between two adjacent rings 734 (one proximal ring and one distal ring) and a second triad beam 732 extending from the distal ring and rotationally offset about 60 degrees relative to the first triad beam.

Fig. 8 shows a tube 804 with a plurality of beams 832 and rings 834. The illustrated cut pattern includes a rotational offset applied at each successive segment of the tube 804 to minimize the preferred bend direction in the tube. As used herein, a "rotational offset" is an angular rotation between two adjacent segments. Thus, a rotational offset is applied from one segment to the next, and even the individual cuts within a segment may be offset from each other.

As shown, the cuts may be arranged to form a substantially uniform rotational offset from one segment to the next. The illustrated cut pattern shows a rotational offset of about 5 degrees from one segment to the next. When multiple continuous segments with such angular offsets are formed, the pattern of beams formed along a sufficient length of the tube 804 is wound around the axis of the tube 804 in a continuously rotating helical pattern. The angular offset may be about 5 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, 75 degrees, 80 degrees, or 85 degrees. In some embodiments, an angular offset is applied at each successive segment. In other embodiments, a plurality of consecutive segments are disposed adjacent to one another without an offset, followed by application of an angular offset.

The illustrated example shows a double beam cutout pattern with a series of rotational offsets. However, it should be understood that the same principles may be applied to other cut patterns, such as a single beam cut pattern in each pair of adjacent rings, a three beam cut pattern, or a cut pattern with more than three beams. In a preferred embodiment, each successive cut or group of cuts along the length of a given segment (e.g., every second cut, every third cut, every fourth cut, etc.) is rotationally offset by about 1, 2, 3, 5, or 10 degrees, or from 180 degrees by about 1, 2, 3, 5, or 10 degrees in a single beam pattern, from 90 degrees by 1, 2, 3, 5, or 10 degrees in a double beam pattern, from 60 degrees by 1, 2, 3, 5, or 10 degrees in a triple beam pattern, and so on for patterns with greater numbers of beams. These rotational offset values advantageously show good ability to eliminate skew deviations.

The individual components and features of the cut patterns shown in fig. 3-8 may be combined to form different tube configurations. For example, some tubes may be configured with a double beam cutout section that transitions to a single beam cutout section.

End modifications

Fig. 9-11 illustrate various distal tip configuration embodiments that may be used with one or more embodiments described herein. Figure 9 shows a continuous diameter tip configuration. Having a substantially continuous diameter at the coil 918 around the tapered core 902. Fig. 10 illustrates a stepped end configuration in which an outer coil 1018 positioned over the core 1002 has a substantially continuous diameter. The smaller diameter inner coil 1014 is positioned to extend more distally than the outer coil 1018 to provide a stepped change in tip diameter. Fig. 11 shows a tapered tip configuration, where the coil 1118 is tapered to match at least a portion of the taper of the core 1102. The tip embodiments shown in fig. 9-11 may be combined with any of the guidewire device embodiments described herein. For example, a desired tip configuration may be selected to provide desired formability and/or flexibility characteristics for a given guidewire application.

The terms "about," "about," and "substantially" as used herein mean an amount or condition that is close to the recited amount or condition, which still performs the desired function or achieves the desired result. For example, the terms "about," "about," and "substantially" may refer to an amount or condition that deviates from the stated amount or condition by less than 10%, or by less than 5%, or by less than 1%, or by less than 0.1%, or by less than 0.01%.

Elements described with respect to any embodiment depicted and/or described herein may be combined with elements described with respect to any other embodiment depicted and/or described herein. For example, any of the elements described with respect to the tube section of any of fig. 3-8 and/or any of the elements described with respect to the tip configuration of any of fig. 9-11 may be combined and used with the guidewire device of fig. 1A, 1B, and 2. In any of the foregoing combinations, the distal tip of the core wire may be rounded, flattened, or otherwise shaped.

The present invention may be embodied in other forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (14)

1. A guidewire device having a shapeable tip, the guidewire device comprising:

a core having a proximal section and a distal section, the distal section having a smaller diameter than the proximal section;

a tube structure coupled to the core such that a distal section of the core enters and distally beyond the tube structure to form a shapeable tip, wherein the tube structure comprises a plurality of fenestrations defining a plurality of axially extending beams coupled with a plurality of circumferentially extending rings;

a braided material coupled to a distal end of the tube structure and extending distally from the tube structure; and

a polymeric cover surrounding a portion of the core extending distally beyond the tube structure and forming at least a portion of the shapeable tip, the shapeable tip configured for shaping into a shaped configuration relative to the tube structure and configured to retain the shaped configuration against a counter force applied by the tube structure.

2. The guidewire device of claim 1, wherein the distal section of the core tapers from the proximal section of the core.

3. The guidewire device of claim 1, wherein the shapeable tip extends distally beyond the tube a distance of about 0.5cm to 5cm, or a distance of about 1cm to 3cm.

4. The guidewire device of claim 1, further comprising a coil partially disposed within the tube structure and partially extending distally beyond the tube structure.

5. The guidewire device of claim 4, wherein a portion of the coil that extends distally beyond the tube structure is encased by the polymeric covering.

6. The guidewire device of claim 4, wherein the portion of the coil disposed within the tubular structure wraps around the core and is positioned between an outer surface of the core and an inner surface of the tubular structure.

7. The guidewire device of claim 4, wherein the coil is sized and shaped to occlude a space between the core and the tubular structure such that a curvature of the tubular structure conforms to a curvature of an overlapping portion of the core when the tubular structure is bent.

8. The guidewire device of claim 4, wherein the coil is formed of a radiopaque material.

9. The guidewire device of claim 1, wherein the tube structure is formed of nitinol.

10. The guidewire device of claim 1, wherein the core is formed of stainless steel.

11. The guidewire device of claim 1, wherein the polymeric covering comprises a radiopaque material.

12. The guidewire device of claim 1, wherein the plurality of fenestrations are arranged in one or more of a single-beam cut pattern, a double-beam cut pattern, or a triple-beam cut pattern.

13. The guidewire device of claim 1, wherein the fenestrations define a cut pattern having a rotational offset such that each successive segment along the length of the tubular structure is rotated circumferentially from a previous segment.

14. The guidewire device of claim 1, wherein the fenestrations define a cut pattern having cuts with increasing depths toward the distal end of the tube structure and/or with decreasing spacing between successive cuts toward the distal end of the tube structure.

Images